OpenTex

GUDID 08800039000604

PURGO BIOLOGICS Inc.

Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable

• Primary Device ID: 08800039000604
• NIH Device Record Key: 665b6934-f712-4485-a8e5-97c57c170f6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OpenTex
• Version Model Number: OpenTex_02
• Company DUNS: 687429456
• Company Name: PURGO BIOLOGICS Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800039000604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222549

FDA Product Code

• NPK: Barrier, Synthetic, Intraoral

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-25
• Device Publish Date: 2023-05-17

On-Brand Devices [OpenTex]

• 08800039000949: OpenTex_T0610
• 08800039000932: OpenTex_T0605
• 08800039000925: OpenTex_T0510
• 08800039000918: OpenTex_T0505
• 08800039000901: OpenTex_T0410
• 08800039000895: OpenTex_T0405
• 08800039000888: OpenTex_T0310
• 08800039000871: OpenTex_T0305
• 08800039000864: OpenTex_T0210
• 08800039000857: OpenTex_T0205
• 08800039000840: OpenTex_T0110
• 08800039000833: OpenTex_T0105
• 08800039000826: OpenTex_T06
• 08800039000819: OpenTex_T05
• 08800039000802: OpenTex_T04
• 08800039000796: OpenTex_T03
• 08800039000789: OpenTex_T02
• 08800039000772: OpenTex_T01
• 08800039000765: OpenTex_0610
• 08800039000758: OpenTex_0605
• 08800039000741: OpenTex_0510
• 08800039000734: OpenTex_0505
• 08800039000727: OpenTex_0410
• 08800039000710: OpenTex_0405
• 08800039000703: OpenTex_0310
• 08800039000697: OpenTex_0305
• 08800039000680: OpenTex_0210
• 08800039000673: OpenTex_0205
• 08800039000666: OpenTex_0110
• 08800039000659: OpenTex_0105
• 08800039000642: OpenTex_06
• 08800039000635: OpenTex_05
• 08800039000628: OpenTex_04
• 08800039000611: OpenTex_03
• 08800039000604: OpenTex_02
• 08800039000598: OpenTex_01